- Pfizer (South San Francisco, CA)
- …the development and management of clinical protocols and amendments, investigator brochures, clinical study reports, statistical analysis plan, and regulatory ... documents. + Provide leadership to early stage clinical scientists on the clinical study team for Early Development Assets, working in a matrix team environment with other clinicians, statisticians, clinical pharmacologists, translational biologists and… more
- AbbVie (Irvine, CA)
- …analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and ... other program documents. *May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs. *May serve on or co-chair Integrated Evidence Strategy Team(s), with responsibility for development of a… more
- AbbVie (South San Francisco, CA)
- …population PK reports, exposure-response analyses reports, relevant section of investigator brochures, common technical documents, white papers, and other similar ... documents. + Conduct data analyses including non-compartmental analyses, modeling and simulation, literature data analyses. + Participate and present at various departmental and cross functional teams such as study teams, clinical pharmacology and… more
- IQVIA (Carlsbad, CA)
- …are available for filing in the Trial Master File (TMF) and verify that the Investigator 's Site File (ISF) is maintained in accordance with GCP / ICH and local ... regulatory requirements. * Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. * Act as a… more
- Sumitomo Pharma (Sacramento, CA)
- …evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. **Job Duties and Responsibilities** + ... Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator communications (Dear Health Care Provider… more
- Bausch + Lomb (Sacramento, CA)
- …ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and changes in scope, schedule, ... and resources. + Organize investigator and expert meetings relevant to the indication and...handled by the CRAs and responded to by the site/ investigator in a timely manner. May assist in the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in GxP Auditing with a successful track record of leading clinical/ investigator site audits. + Broad experience participating in cross-functional projects and ... Proficient in GxP Auditing with a successful track record of leading clinical/ investigator site audits. + Thorough knowledge of standards, systems, policies, and… more
- Taiho Oncology (Pleasanton, CA)
- …relevant clinical documents of high quality, such as study protocol protocol(s), investigator brochure (IB), informed consent forms (ICF), case report forms (CRF), ... assessments for the study conduct and operational risks. Represent the molecule at senior management governance meetings. + Mentoring and training of junior staff in… more
- Taiho Oncology (Pleasanton, CA)
- …transforming the landscape of cancer treatment and improving patients' lives. As a Senior Manager, Clinical Research Scientist, you will play a pivotal role in our ... to be at the forefront of cancer research. Position Summary: The Senior Manager, Clinical Research Scientist has responsibility assisting in design, execution and… more
- Cedars-Sinai (Los Angeles, CA)
- …cooperation with Piotr Slomka, PhD, Director, Innovation in Imaging and Principal Investigator , as part of a medical imaging and artificial intelligence research ... projects and proposals. + Assists in the preparation of grant proposals of Senior Investigators. + Compiles, analyzes, interprets, and summarizes data. + May submit… more